Efficacy and safety of denileukin diftitox retreatment in patients with relapsed cutaneous T-cell lymphoma

Abstract

This open-label phase III trial, a companion to an earlier placebo-controlled trial, evaluated safety and efficacy of denileukin diftitox (DD) in patients with cutaneous T-cell lymphoma (CTCL) who relapsed after responding to DD primary treatment in the earlier trial. Twenty relapsed patients (stages IA–III) received DD 18 μg/kg/day intravenously on days 1–5 of a 21-day cycle, for ≤8 cycles. Efficacy was assessed monthly during the first year then every 3 months. The overall response rate was 40%, mostly partial responses. Nine patients (all baseline stages ≤ IIA) experienced progression. Intent-to-treat median progression-free survival was 205 days, and median duration of response was 274 days. The most common adverse events were nausea, upper respiratory tract infections, fatigue and rigors. Three patients withdrew because of toxicity. This study showed that DD may provide clinically meaningful benefit in patients with CTCL who relapsed after initial response to DD.

Keywords::

• Denileukin diftitox
• antigens
• CD25
• mycosis fungoides
• Sezary syndrome
• cutaneous T-cell lymphoma

Acknowledgements

The authors thank Kara Nyberg, PhD, of Sui Generis Health and Yvonne E. Yarker, PhD, CMPP, of Peloton Advantage for providing medical writing and editorial assistance during the development of the manuscript.

Potential conflict of interest:

Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.

This study was funded by Eisai Inc. and Ligand Pharmaceuticals. Medical writing, editing and graphics assistance was provided by Sui Generis Health and by Peloton Advantage, LLC, and was funded by Eisai Inc.